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Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients

NCT05586971 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2202

Last updated 2025-07-22

No results posted yet for this study

Summary

The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.

Conditions

  • Gout
  • Hyperuricemia
  • Gout Flare
  • Tophi

Interventions

DRUG

Tigulixostat

Xanthine Oxidase Inhibitor

DRUG

Allopurinol

Xanthine Oxidase Inhibitor

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • LG Chem

    lead INDUSTRY

Principal Investigators

  • Hyungjin Cho, MD · LG Chem

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2025-05-06
Completion
2025-05-06
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Colombia
  • Czechia
  • France
  • Georgia
  • Germany
  • Italy
  • Lithuania
  • Malaysia
  • New Zealand
  • Philippines
  • Poland
  • South Korea
  • Spain
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05586971 on ClinicalTrials.gov